BEUDAMED
    FDA Adverse Event Other Summary report: N

    NEBULIZERS TO DELIVER AEROSOLS

    MDR report key: 2120490 · Received June 3, 2011

    Report

    Report Number
    1525712-2011-00231
    Event Type
    Other
    Date Received
    June 3, 2011
    Date of Event
    April 21, 2011
    Report Date
    June 2, 2011
    Manufacturer
    MEDEL
    Product Code
    CAF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SERIOUS INJURY ALLEGED. PRODUCT WAS IN USE WHEN UNIT ALLEGEDLY EMITTED SMOKE AND SMELLED LIKE SMOKE. PRODUCT WAS APPROXIMATELY 2 1/2 YEARS OLD AT THE TIME OF THE INCIDENT WITH NO PREVIOUS COMPLAINTS. MAINTENANCE HISTORY IS UNKNOWN. HISTORY HAS SHOWN THAT EVENTS WITH THIS DEVICE HAVE BEEN A RESULT OF DROPPING THE DEVICE, MECHANICAL WEAR AND / OR BLOCKING THE VENTS DURING USE. THE DEVICE IS THERMALLY PROTECTED. THE DEVICE HAS NOT BEEN RETURNED AT THIS TIME SO MALFUNCTION HAS NOT BEEN CONFIRMED. MDR FILED SOLELY ON SMOKE AND BURNING SMELL COMPLAINT.

    Description of Event or Problem · 1

    THE CONSUMER WAS TAKING A BREATHING TREATMENT WHEN THE UNIT ALLEGEDLY STARTED TO SMOKE AND HAD A BURNING SMELL. NO INJURY IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEBULIZERS TO DELIVER AEROSOLS 868.5630 CAF MEDEL IRC1710

    Patients

    Seq Age Sex Outcome Treatment
    1